Catheters with non-removable guide members useable for treatment of sinusitis

ABSTRACT

Balloon catheter, guide catheter and method for dilating openings in paranasal sinuses. A non-removable guide member (e.g., guidewire) extends from the distal end of the balloon catheter. The non-removable guide member initially passes through the opening of the paranasal sinus and is followed by the catheter body on which the balloon is mounted. The balloon is then inflated causing dilation of the opening of the paranasal sinus. In some embodiments, the non-removable guide member may be shapeable so that the operator may place the non-removable guide member in a desired shape prior to insertion of the balloon catheter. In some embodiments, the length of the non-removable guide member may be adjustable such that the operator may adjust the length of the non-removable guide member prior to insertion of the balloon catheter.

RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/150,847 entitled “Devices, Systems and Methods Useable forTreating Sinusitis” filed Jun. 10, 2005, issued Sep. 9, 2010 as U.S.Pat. No. 7,803,150, the entire disclosure of which is expresslyincorporated herein by reference. Additionally, this application is acontinuation-in- part of and copendinq U.S. patent application Ser. No.11/193,020 entitled “Methods and Apparatus for Treating Disorders of theEar, Nose and Throat” filed on Jul. 29, 2005.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsand more particularly to minimally invasive, devices, systems andmethods for treating sinusitis and other ear, nose & throat disorders.

BACKGROUND

Balloon angioplasty catheters have been used to treat cardiovasculardisorders for many years. In general, balloon angioplasty catheters ofthe prior art have included over-the-wire catheters, which ride over aseparate guide wire, which represent the majority of balloon catheters,fixed-wire catheters, which combine the balloon catheter and guide wireinto one device, and rapid exchange catheters, which are essentiallyover-the-wire type catheters with short guidewire lumens that allow thecatheter to be exchanged without the use of an extension wire.

The fixed wire balloon angioplasty catheters of the prior art havetypically ranged in length from about 120 cm to about 150 cm and havehad balloon dimensions and flexural properties that were suitable forperforming balloon angioplasty procedures in coronary or peripheralblood vessels. Examples of commercially available fixed-wire balloonangioplasty catheters include the Ace™ balloon catheters (BostonScientific, Inc., Natick, Mass.).

More recently, procedures have been developed wherein balloon cathetersare used to dilate the ostia (or other openings) of paranasal sinusesfor the treatment of disorders such as sinusitis. In these procedures, aballoon catheter or other dilator catheter is advanced transnasally intoan opening of a paranasal sinus and used to dilate that opening, therebyimproving drainage and ventilation of the affected sinus. In someembodiments, a guide catheter is initially inserted into the nose, aguidewire is then advanced through the guide catheter and the ballooncatheter is then advanced over the guidewire. In other embodiments, asdescribed in parent application U.S. patent application Ser. No.11/150,847, issued as U.S. Pat. No. 7,803,150, the balloon catheter maybe equipped with a non-removable guide member that extends from itsdistal end and is advanceable through the ostium of the paranasal sinusahead of the catheter shaft and balloon. The provision of suchnon-removable guide member extending from the distal end of the ballooncatheter eliminates the need for use of a separate guidewire, therebysimplifying the procedure, shortening the procedure time, reducing theneed for an assistant, and decreasing the amount of radiation exposureto the patient and operator due to use of fluoroscopy.

There remains a need in the art for further development and refinementof balloon catheters (and other dilator devices) that have non-removableguide members for use in dilating the ostia of paranasal sinuses.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided a ballooncatheter device for dilating an opening of a paranasal sinus in a humanor animal subject. In general, this balloon catheter device comprises;(a) a catheter shaft having a proximal end and a distal end, (b) anon-compliant or semi-compliant balloon (or other suitable dilator)mounted on the catheter shaft, such balloon being positionable withinthe opening of the paranasal sinus while in a non-inflated state andthereafter inflatable to an inflated state such that it will causedilation of the opening of the paranasal sinus, (c) at least oneposition indicating element useable to determine when the balloon ispositioned within the opening of the paranasal sinus and (d) anon-removable guide member, at least a portion of which extends from thedistal end of the catheter shaft, said non-removable guide member havinga limited range of axial movement or no movement relative to thecatheter shaft, said non-removable guide member being advanceablethrough the opening of the paranasal sinus ahead of the catheter shaft.Such balloon catheter device has a length less than about 20 cm. In someembodiments, the guide member may be attached to the catheter device ina substantially fixed position. In other embodiments, the guide membermay be attached to the catheter device in a manner that allows the guidemember to undergo rotational movement and/or some limited range oflongitudinal movement (e.g., axial translation). In some embodiments theguide member may extend through all or part of the catheter shaft, withonly a portion of the guide member protruding beyond the distal end ofthe catheter shaft. In other embodiments, the guide member may beattached to the distal end of the catheter shaft such that little or nopart of the guide member actually extends into the catheter body. Insome embodiments, the catheter shaft may be formed of plastic while inother embodiments the catheter shaft may be formed of metal (e.g.,hypotube). In some embodiments, the catheter device may be used inconjunction with a straight or curved guide catheter. In otherembodiments, the catheter device may be inserted into the opening of aparanasal sinus without the use of a guide catheter.

Further in accordance with the invention there is provided a guidecatheter through which the above-summarized balloon catheter device maybe inserted. Such guide catheter may comprise an outer metal tube and aplastic tube that extends coaxially through the lumen of the metal tubewith a distal portion of the plastic tube extending out of and beyondthe distal end of the metal tube. The portion of the plastic tube thatextends beyond the distal end of the metal tube may be straight orcurved. In some embodiments, an outer cover may extend over all or partof the outer surface of the guide catheter and such outer cover mayserve to smooth the transition between the distal end of the metal tubeand the adjacent surface of the protruding portion of the plastic tube.In some embodiments, an inner liner (e.g., a lubricious liner) may lineall or part of the lumen of the inner plastic tube.

Still further in accordance with the present invention, there isprovided a method for dilating an opening of a paransal sinus in a humanor animal subject. This method generally comprises the steps of; (A)providing a balloon catheter that has a non-removable guide member thatextends from its distal end, (B) trans-nasally inserting the ballooncatheter and causing at least part of the non-removable guide member topass through an opening of the paranasal sinus, (C) moving the ballooncatheter to a location where the balloon is positioned within theopening of the paranasal sinus and (D) inflating the balloon to causedilation of the opening of the paranasal sinus.

Further aspects, details and embodiments of the present invention willbe understood by those of skill in the art upon reading the followingdetailed description of the invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a guide catheter/non-removable wire ballooncatheter system of the present invention.

FIG. 1A is a side view of the non-removable wire balloon catheter shownin FIG. 1.

FIG. 1B is a side view of the guide catheter shown in FIG. 1.

FIG. 2 is a cross sectional view through the longitudinal axis of thenon-removable wire balloon catheter of FIG. 1A.

FIG. 2A is a cross sectional view through line 2A-2A of FIG. 2.

FIG. 2B is a cross sectional view through line 2B-2B of FIG. 2.

FIG. 2C is a cross sectional view through line 2C-2C of FIG. 2.

FIG. 2D is a cross sectional view through line 2D-2D of FIG. 2.

FIG. 2E is cross sectional view through the longitudinal axis of analternative embodiment of a non-removable wire balloon catheter of thepresent invention.

FIG. 2F is cross sectional view through the longitudinal axis of yetanother alternative embodiment of a non-removable wire balloon catheterof the present invention.

FIG. 3 is a partially sectioned side view of the non-removable guidewirecomponent included in the balloon catheters shown of FIGS. 1A, 2E and2F.

FIG. 4 is a partial longitudinal sectional view through a ballooncatheter of the present invention showing an alternative construction atthe location where the proximal end of the balloon is mounted on theouter catheter shaft.

FIG. 5A is another side view of the guide catheter of FIG. 1B, with thecatheter rotated 90 degrees from that seen in FIG. 1B.

FIG. 5B is a cross sectional view through line 5C-5C of FIG. 5A.

FIG. 5C is an enlarged view of region 5C of FIG. 5B.

FIG. 5D is an enlarged cross sectional view through Line 5D-5D of FIG.5B.

FIG. 5E is an enlarged view of region 5E of FIG. 5B.

FIG. 5F is an enlarged view of region 5F of FIG. 1B.

FIG. 5G is a cross sectional view through line 5G of FIG. 5A.

FIGS. 6A and 6B are schematic diagrams showing a device and method forforming the curve in the guide catheter of FIG. 1B.

FIGS. 7A-7E show steps in a method for using the system of FIG. 1 toenlarge the ostium of a maxillary sinus in a human subject.

FIG. 8 is a cross sectional view through a longitudinal axis of anotherembodiment of a non-removable wire balloon catheter, having a curvedhypotube shaft.

FIG. 8A is an enlarged view of a distal portion of FIG. 8.

FIG. 9 is a cross sectional view through a longitudinal axis of anotherembodiment of a non-removable wire balloon catheter, having a straighthypotube shaft.

FIG. 9A is an enlarged view of a distal portion of FIG. 9.

DETAILED DESCRIPTION

The following detailed description and the accompanying drawings areintended to describe some, but not necessarily all, examples orembodiments of the invention. The contents of this detailed descriptionand the accompanying drawings do not limit the scope of the invention inany way.

The term “opening of a paranasal sinus” as used herein shall, unlessotherwise stated, include any and all trans-nasally accessible openingin a paranasal sinus or air cell including but not limited to; naturalostia, surgically altered natural ostia, surgically created openings,antrostomy openings, ostiotomy openings, burr holes, drilled holes,ethmoidectomy openings, natural or man made passageways, etc.

The term “diagnostic or therapeutic substance” as used herein is to bebroadly construed to include any feasible drugs, prodrugs, proteins,gene therapy preparations, cells, diagnostic agents, contrast or imagingagents, biologicals, etc. Such substances may be in bound or free form,liquid or solid, colloid or other suspension, solution or may be in theform of a gas or other fluid or nan-fluid. For example, in someapplications where it is desired to treat or prevent a microbialinfection, the substance delivered may comprise pharmaceuticallyacceptable salt or dosage form of an antimicrobial agent (e.g.,antibiotic, antiviral, antiparasitic, antifungal, etc.), acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an agent that prevents of modifies anallergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), etc. Othernon-limiting examples of diagnostic or therapeutic substances that maybe useable in this invention are described in copending U.S. patentapplication Ser. No. 10/912,578 entitled Implantable Devices and Methodsfor Delivering Drugs and Other Substances to Treat Sinusitis and OtherDisorders filed on Aug. 4, 2004, issued as U.S. Pat. No. 7,361,168 onApr. 22, 2008, the entire disclosure of which is expressly incorporatedherein by reference.

The term “nasal cavity” as used herein shall, unless otherwise stated,be broadly construed to include any cavity that is present in theanatomical structures of the nasal region including the nostrils andparanasal sinuses.

The term “trans-nasal” as used herein shall mean through a nostril.

In general, FIGS. 1-5H show catheters devices of the present invention,FIGS. 6A and 6B show a device and method for forming a curve in a guidecatheter device of the present invention and FIGS. 7A-7E show oneembodiment of a method for using catheter devices of the presentinvention to treat sinusitis in a human subject.

With reference to FIGS. 1-2D, one embodiment of a system 10 of thepresent invention comprises a non-removable wire balloon catheter 12 anda guide catheter 14. Although shown and described as a system it is tobe appreciated that the non-removable wire balloon catheter 12 and guidecatheter 14 need not necessarily be used in combination, but rather mayalso be used independently of one another.

Non-Removable Wire Balloon Catheter

The embodiment of the non-removable wire balloon catheter 12 shown inFIGS. 1-2E comprises an elongate, flexible catheter shaft 16 having aballoon 18 mounted thereon. A proximal Luer hub 20 is attached to theproximal end of the catheter shaft 16. An inflation device (not shown)may be attached to the Luer hub 20 and used to inflate and deflate theballoon 18. A non-removable guide member 22 extends out of and beyondthe distal end DE of the catheter shaft 16.

In one preferred embodiment for adult applications, balloon catheter 12has an overall length of approximately 43.5 cm and its shaft 16 has anouter diameter of about 0.058 inches.

As seen in FIG. 2, in this embodiment, the catheter shaft 16 comprisesan outer tube 30 which extends from the hub 20 through the proximal end32 of balloon 18. An inner tube 34 is positioned coaxially within theouter tube 30 and extends from the mid-region of the outer tube 30 andthrough the distal end of the balloon 36. As shown, the proximal end ofthe balloon 32 is attached by adhesive, thermal bonding or othersuitable means to the outer surface of the outer tube 30 and the distalend of the balloon 36 is attached by adhesive, thermal bonding or othersuitable means to the outer surface of the inner tube 34. The balloonhas a cylindrical sidewall with tapered portions adjacent to theproximal end 32 and distal end 36. The length of the cylindrical portionof the balloon 18 is referred to herein as the balloon's working lengthWL. The working length WL of balloon 18 may, in some embodiments, rangefrom 4 mm to 35 mm. In one preferred embodiment, the working length ofthe balloon is around 16 mm+/−1 mm. In another preferred embodiment, theworking length of the balloon is around 24 mm+/−1 mm. Balloon 18 may beinflated to a suitable working pressure of around 12 to 16 atmospheres.

Optionally, position indicators, such as radiopaque markers 38, 40 maybe mounted on the inner tube 34 within the balloon 18 to mark thelocations of the proximal and distal ends of the working length WL.Balloon 18 may be coated with one or more balloon coatings including,but not limited to puncture resistance coating, abrasion resistancecoating, anti-tack coating, lubricous, hydrophilic, etc. In a particularembodiment, balloon 18 is made of PET of a wall thickness around 0.001inches coated by a 0.001 inch thick polyurethane coating with a tensilestrength of 12,000 to 16,000 psi and a burst pressure of more than 16atmospheres. In some embodiments, a portion of the non-removable guidemember 22 may extend through the balloon 18 and that portion of thenon-removable guide member 22 may be radiopaque or otherwiseradiographically distinguishable from the rest of the non-removableguide member 22 so as to indicate the position of balloon 18 as well asthe position of the non-removable guide member distal end.

As seen in FIGS. 2 and 3, the non-removable guide member 22 of thisembodiment extends fully through the catheter shaft 16 such that only aportion of this guide member 22 protrudes beyond the distal end of thecatheter shaft 16. The guide member 22 is constructed to impartdiffering degrees of stiffness to different regions of the cathetershaft 16. In this regard, as may be best appreciated from FIG. 3, theguide member 22 generally comprises a proximal portion or region 60, amiddle portion or region 62 and a distal portion or region 64. Thisguide member 22 is constructed of a core wire 66, an outer coil 68 andan inner coil 70. In some embodiments, the core wire may be of constantdiameter over its entire length. However, in the example shown, the corewire 66 has sections of differing diameter and, hence, differingstiffness. In this example, a proximal section 68 of core wire 66 makesup the proximal region 60 of guide member 22 and is of uniform constantdiameter, typically in the range of 0.014 mm to 0.038 in someembodiments and of 0.025+/−0.0005 inch in other embodiments. Theparticular diameter and/or rigidity of this proximal portion or region60 may be selected to provide sufficient support to the balloon whileremaining small enough to reduce shaft profile and inflation anddeflation time of the balloon.

Within the middle region 62 of the guide member 22, the core wire 66 hasa number of stepped down areas, namely a first tapered section 72, afirst constant diameter section 74 of uniform constant diameter (e.g.,in the range of 0.006 to 0.012 inches), a second tapered section 76 anda second constant diameter section 78 of uniform constant diameter(e.g., in the range of 0.002 to 0.008 inches). The distal region 78 ofconstant diameter may have some or all of its length flattened orpartially flattened to fine tune the distal flexibility of theguidewire. The guidewire should be very flexible near the proximal endof region 64 to enable the guidewire to conform to the internal contoursof the sinus anatomy. In some embodiments, this distal section 80 of thecore wire 66 may be flattened (e.g., cut, swaged, etc.) while theremaining portions of the core wire 66 may be substantially round. Inembodiments where the distal section 70 of the core wire 66 isflattened, the height of the flat is generally between from about 0.001inch to about 0.004 inch. Such flattening of the distal section 70 ofthe core wire 66 accomplishes the purpose of making the distal region 64more flexible in one plane (e.g., up and down) than in another plane(e.g., side to side), thereby rendering the distal portion 64 morelikely to form a smooth curl within the sinus cavity as it is advancedthrough the sinus opening.

An outer helical coil, such as a stainless steel wire coil, is affixedto the first tapered section 72 within the middle region 62 and extendsto the distal tip of the guide member 22. An inner helical coil,platinum/tungsten alloy, is disposed within the outer coil 70 and aroundpart of the distal section 80 of the core wire 66, as shown. Thisconstruction forms an atraumatic tip that is sufficiently stiff to passthrough the nasal and paranasal anatomy and floppy enough to bucklewithout causing damage to the nasal and paranasal tissue. Theplatinum/tungsten alloy provides a radiopaque marker to identify the tipof the non removable guide member 22 when viewed fluoroscopically.

Two design parameters, namely the diameters and/or relative stiffness ofthe various sections 68, 72, 74, 76, 78, 80 and material of which thecore wire 66 is constructed, can be of particular importance in allowingthe non-removable guide member 22 to achieve its desired function. Inthe preferred embodiment, core wire 66 is made of nickel-titanium alloy(Nitinol) which has high elasticity. The high elasticity of thenickel-titanium core wire 66 enables the balloon catheter shaft 16 topass easily through regions of guide catheter 14 that have sharp bendsor curves without kinking of the core wire 66. The constant diametersection 74 is the region where the balloon is located. The diameter ofthis section should be small enough to avoid creating excessivestiffness which would create resistance when advancing the ballooncatheter through the tip of the guide catheter. However, the diameter ofregion 74 must be large enough to prevent guidewire buckling and supportthe balloon as the catheter is advanced. Most importantly, the diameterof region 74 and the gradual taper of region 76 must allow the guidewireto bend in a relatively smooth arc without kinking where the nonremovable guide member 22 exits the distal end of the balloon 18. In oneembodiment the optimal diameter of constant diameter section 74 has beendetermined to be between 0.006 to 0.012 inches. This diameter can beused to develop catheters for various sinus anatomies and locations. Forinstance, a catheter designed to extend a significant distance out thetip of a relatively straight guide could use a larger diameter. Acatheter for use in a shaped guide needs a smaller diameter to reduceresistance through the guide. The length of non-removalable guide member22 extending out the distal end of the balloon 18 should be long enoughto partially define the outline of the sinus cavity when viewedfluoroscopically but not so long that an excessive length of guidewiretip must be advanced into small sinus cavities. In a preferredembodiment, the length is between about 3 cm and about 6 cm.

The proximal end of the outer tube 30 is received within hub 20 and anouter sleeve 44 may be formed about the area where the outer tube 30enters the hub 20. Labeling may be printed on this sleeve 44 and,optionally, this sleeve 44 may act as a strain relief member.

As seen in FIGS. 2 and 2D, a crimpable member such as a metal hypotube48 is attached to the proximal end of section 68 of core wire 66 andextends into the hub 20, where it is surrounded by a plastic hypotubecover 50. The hypotube 48 is crimped inwardly so as to frictionallyengage and hold the proximal section 68 of core wire 66 within hub 20.As seen in the cross section view of FIG. 2D, the hypotube 48 may becrimped at discrete locations so as to provide flow channels 90 throughwhich balloon inflation fluid may flow.

As shown in FIG. 1A, a short distal marker 116 and a long proximalmarker 118 may be formed on the catheter shaft 16. Distal marker 116 andlong proximal marker 118 enable the user to determine the relativelocation of various regions of balloon catheter device 12 relative tothe distal tip of guide catheter 14 without requiring the use offluoroscopy. For example, the distal marker 116 may be approximately 1.5mm long and long proximal marker 118 may be approximately 20 mm long.Also, the distal end of distal marker 116 may be located approximately127 mm from the distal tip of guide member 22 and the proximal end oflong proximal marker 93 may be located approximately 131 mm from theproximal end of the balloon 18. These markers 116, 118 are useable invarious ways. For example, as described more fully herebelow, theballoon catheter 12 may be useable in conjunction with a specially sizedguide catheter 14 as seen in FIG. 1B. In typical usage, the distal endof the non-removable guide member 22 will be inserted into the proximalLuer hub 108 of guide catheter 14 and the balloon catheter 12 will beadvanced through the guide catheter 14. The balloon catheter 12 may besized relative to the guide catheter 14 such that, when the distalmarker 116 is even with and about to enter the proximal end of the Luerhub 108 of guide 14, the distal end DE of non-removable guide member 22will be even with and about to emerge out of the distal end DE of guidecatheter 14. Also, when the proximal end of long proximal marker 118 iseven with the Luer hub 108 of guide 14, the end of the balloon 36 willbe even with and about to emerge out of the guide catheter 14. Also,when the proximal end of long proximal marker 118 is even with and aboutto enter the proximal end of the Luer hub 108 of guide 14, the proximalend of the balloon 32 will be even with the distal end of the guidecatheter 14 and the entire balloon 18 will have emerged out of thedistal end of the guide catheter 14.

In embodiments where the balloon catheter 12 is to be inserted through acurved guide catheter 14, it may be desirable to design the proximaljoinder of the balloon 18 to the catheter shaft 16 in such a way as tominimize the likelihood for snagging or catching of the proximal end 32of the balloon 18 as the balloon catheter 14 is pulled back through thecurved portion of the guide. FIGS. 2E and 2F show alternativeembodiments of the balloon catheter 10 a, 10 b which are designed toaccomplish this. Also, FIG. 4 shows an alternative construction of thecatheter shaft 16 at the location where the proximal balloon end 32 isaffixed to the catheter shaft 16.

The balloon catheter 10 a shown in FIG. 2E is the same as that shown inFIG. 2, except that in the catheter 10 a of FIG. 2E the balloon 18A isformed in the distal portion of an elongated balloon tube member 90which extends proximally to a location near the middle of the cathetershaft where it is bonded to outer tube 30. In this manner, the seambetween the proximal end of balloon tube member 90 and outer tube 30 islocated proximally enough to avoid any passing through (or beingretracted through) the curved region of the guide catheter 14.

The balloon catheter 10 b shown in FIG. 2F is the same as that shown inFIG. 2 except that in the catheter 10 b of FIG. 2F, the outer tube 30 isabsent and an elongated balloon tube 92 extends all the way to theproximal end of the catheter body where it is received within the sleeve44 and is bonded to hypotube 48. In this manner, the catheter body isessentially seamless from the balloon 18 n all the way proximal to thehub 20, thereby eliminating any potential for a seam to snag or catch onthe curvature in the guide catheter 14.

With reference to FIG. 4, in some embodiments of the catheter device 10such as that shown in FIGS. 1-2D, a modified outer tube 30 a may be usedwherein the outer diameter of such outer tube 30 a is reduced at thelocation where the proximal end 32 of the balloon 18 is affixed, therebyproviding a smoothed transition and deterring the proximal end 32 ofballoon 18 from snagging or catching as it is retracted through a curvedguide catheter or the like.

Guide Catheter

An example of the preferred guide catheter 14 is shown in FIGS. 2B and5A-5G. As shown, the guide catheter 14 comprises an elongate shaft 102.Guide catheter 14 is made of suitable biocompatible materials asdescribed below. The distal portion of the shaft 102 incorporates acurve 101. Various embodiments of guide catheter 14 may be designed withunique curves formed therein to access specific anatomical locations.Or, in some embodiments, the guide catheter shaft 102 may be malleableso that the operator may form the shaft 102 to a desired shape prior toor during the procedure. In another embodiment (not shown), the guidecatheter 14 shaft may be straight, without any curvature. Guidecatheters 14 having different angles A of curve 101 may be used, forexample, to access one or more anatomical regions in the nasal cavityincluding, but not limited to ostia of various paranasal sinuses.

In the example shown in the drawings, the elongate shaft 102 of theguide catheter 14 is formed of an outer metal tube such as a hypotube114 having a plastic tube 112 extending coaxially therethrough with adistal portion 100 of the plastic tube 112 protruding out of and beyondthe distal end of the hypotube 114, as seen in FIG. 5F. The hypotube inthis example is traditional stainless steel hypotube material. However,it will be appreciated that this hypotube 114 element may be formed ofany suitable material having the desired stiffness, such as stainlesssteel, titanium, nickel-titanium alloys (e.g., Nitinol), polymers suchas Nylon, etc. The plastic tube 112 formed of suitable material such asNylon or other thermoplastic. In the embodiment shown, the radius ofcurvature of the curve 101 is 0.18 inches. In the embodiment shown, theouter diameter of the flared distal end of elongate shaft 102 is0.113+/−0.003 inches and the length of radiopaque marker is 0.04 inches.The length of atraumatic tip 104 ranges from 0.060 to 0.120 inches. Theouter rim of atraumatic tip 104 is radiused. The distal end of outersleeve 106 is tapered as shown and covers elongate shaft 102. In apreferred embodiment shown, the outer diameter of the distal end ofouter sleeve 106 is 0.109+/−0.003 inches.

Optionally, an outer sleeve or cover 106 may be disposed over a portionof the outer surface of hypotube 114 and, in some cases, may extend overat least some of the protruding distal portion 100 of the plastic tube112, thereby providing a smooth outer surface over the area where thedistal end of the hypotube 114 is located. Such outer sleeve or cover106 may be formed of any suitable material such as Nylon or other heatshrinkable thermoplastic.

Also optionally, an inner liner 111 may extend through and line the wallof the lumen of plastic tube 112. This inner liner 111 may be formed ofany suitable material, and preferably a lubricious material, such aspolytetrafluoroethylene PTFE or the like.

In a preferred embodiment, guide device 14 is of a smaller outerdiameter than has been previously known for transnasal treatment ofparanasal sinuses. The construction of the embodiment allows for greateraccess and less trauma to a larger number of patient's sinuses,particularly the maxillary sinuses. The smaller diameter allows for theuse of the guide catheter alongside other instruments, like anendoscope, in the constricted paranasal anatomy. A shorter or morecompact tip allows for greater maneuverability in the tortuous andconstricted anatomy. The smaller diameter of the guide allows easier,less traumatic passage in the paranasal cavities. For example, it iseasier to fit between the nasal septum and the middle turbinate whenaccessing the sphenoid; easier fit into the middle meatus and betweenthe lateral wall of the middle turbinate and the uncinate process andlamina paprycia when accessing the maxillary, frontal, and ethmoidsinuses; easier to fit in the middle meatus and up into the frontalrecess when accessing the frontal sinus. Additionally, the tight/smalldiameter of the distal curve of the guide allows less damage/trauma tothe middle turbinate and uncinate when accessing the maxillary sinus.When the guide is torqued such that the curve of the guide (the plane ofthe curve) is essentially perpendicular to the middle turbinate anduncinate process, it will be easier to fit a smaller curve in thatnarrow space between the middle turbinate and theuncinate/infindiubulum. Additionally, when accessing the maxillarysinus, the smaller diameter guide tip (not curvature radius, but actualdiameter of the tip) is better able to slip behind the uncinate (orbetween the uncinate and lateral wall) and then access the maxillarysinus. With a larger guide catheter, it is not uncommon for the surgeonto tease forward the uncinate process because he was not able to slipthe bigger guide catheter tip behind the uncinate process. It isespecially useful in accessing the maxillary sinus where the guidecatheter tip must be advanced in one orientation to pass by the middleturbinate and then rotated to “hook” the distal end around the uncinateprocess to give access to the maxillary ostium. In the preferredembodiment, the outer cover 106 is made of a length of Nylon 11 tubingwith an inner diameter of 0.125+/−0.001 inches and an outer diameter of0.139+/−0.001 inches. Outer cover 106 substantially surrounds the outersurface of the hypotube and a region of elongate shaft 102 emerging fromthe distal end of the hypotube after it is fused/laminated to theseunderlying surfaces. The final diameter of the shaft over the hypo tuberegion is 0.134+/−0.003″. This embodiment comprising outer cover 106 isespecially useful for providing an outer lubricious surface on guidedevice 14, for improving joint integrity between the hypotube andelongate shaft 102, and creating a smooth transition between the distalportion of elongate shaft 102 and the distal end of the hypotube. Theproximal end of guide device 14 comprises a hub 108. In the embodimentshown, hub 108 is a female Luer hub. The portion of outer cover 106extending beyond the distal end of hub 108 is covered with a length oflabel tubing 110 as shown. The length of label tubing 110 may range from0.5 inches to 1 inch. In an embodiment where the guide catheter 14 has acurve 101 of 110 degrees and is intended for use in accessing amaxillary sinus, the label tubing 110 may be labeled with the code“M-110”, wherein the “M” stands for maxillary sinus and the “110” standsfor the angle of the curved region 101. The length of the portion of theguide device 14 that enters the body may range preferably from 3 inchesto 5 inches, and the length of the portion that remains outside of thebody is preferably at least 0.5 inches. The overall length of guidedevice 14 measured from the distal end of hub 108 to the distal tip ofguide device 14 measured along a curved distal region of elongate shaft102 is 4.25+/−0.25 inches. The length of guide device measured from theproximal end of hub 108 to the distal tip of guide device 14 measuredalong a curved distal region of elongate shaft 102 is 5.16+/−0.15inches. The inner surface of guide device 14 may be lined by alubricious coating or a tubular lubricious liner (not shown). Such alubricious coating or tubular lubricious liner is useful to facilitatepassage of one or more devices through the lumen of guide device 14especially when guide device 14 comprises an angled, curved or bentregion. Proximal portion of guide device 14 may comprise a rotatingvalve device (not shown) such as a Touhy-Borst device to lock down adevice such as a sheath, guidewire, balloon catheter or other devicesthat are being inserted through guide device 14. The distal region ofguide device 14 disclosed has a radiopaque marker 120 (see FIGS. 5E and5F). The radiopaque marker may be made of suitable biocompatiblematerials including, but not limited to, metals, polymers loaded with aradiopaque substance, etc. In one embodiment, multiple guide devices 14of varying designs are provided in a kit.

FIG. 5B shows a longitudinal sectional view of the guide device 14. Theouter diameter of elongate shaft 102 is around 0.113+/−0.001 inches andthe inner diameter of elongate shaft 102 is around 0.095+/−0.001 inchesprior to being fused/laminated to the underlying tubing. In a preferredembodiment, the material of elongate shaft 102 has Rockwell hardness inthe range of about 70R to about 110R. In this preferred embodiment, thedistal portion of elongate shaft 102 is flexible enough to prevent orreduce damage to the anatomy. Yet, the distal portion is rigid enough toretain its shape as one or more devices are passed through guide device14. Furthermore, the distal portion of elongate shaft 102 is rigidenough to enable a user to use the distal portion to displace paranasalstructures. The distal portion of elongate shaft 102 comprises a curvedor angled region 101 curved at an angle ranging from 0 degrees to 135degrees. In a preferred embodiment, the inner surface of elongate shaft102 is lined by a lubricious coating or a tubular lubricious liner 112made of a suitable biocompatible material such as PTFE. In oneembodiment, the inner diameter of lubricious liner 112 in guide device14 is 0.087+/−0.003 inches. In one embodiment, lubricious liner 111 ismade from a PTFE tube of outer diameter 0.093+0.0/−0.001 inches and aninner diameter of 0.089+/−0.001 inches which shrinks to about0.087+/−0.003 inches upon bonding to inner surface of the elongate shaft102. A radiopaque marker 120 (shown in FIG. 1F) is located in the distalregion of elongate shaft 102 between plastic tube 112 and lubriciousliner 112. The liner 111 extends beyond the distal end of plastic tube112 and underlying marker 120 and the atraumatic tip member 104 isdisposed about and secured to the distal end of the liner 111, as seenin the enlarged view of FIG. 5E. The atraumatic tip 104 may be formed ofsuitable biocompatible materials including, but not limited to apolyether block amide (Pebax 40D). Atraumatic tip 104 prevents orreduces accidental damage to the anatomy caused by the distal tip ofguide device 14. In one embodiment, length of atraumatic tip 104 rangesfrom 0.060 to 0.120 inches. The material of atraumatic tip 104 can havea Shore Durometer hardness in the range of about 35D to about 72D. Guidedevice 14 further comprises a hypotube 114 to which elongate shaft 102and outer cover 106 are attached. In a preferred embodiment, the outerdiameter of hypotube 114 is 0.120+/−0.001 inches and the inner diameteris 0.112+/−0.002 inches. In a preferred embodiment of guide device 14,no portion of hypotube 114 is exposed to bodily fluids. In oneembodiment of a method of constructing guide device 14, a stainlesssteel hypotube 114 is bonded to an elongate shaft 102 such as a Nylontube to increase the strength of elongate shaft 102. In one embodimentof bonding hypotube 114 to elongate shaft 102, hypotube 114 is heatbonded to elongate shaft 102. One or more openings, perforations orholes may be located on hypotube 114 to enable material of elongateshaft 102 to melt into the one or more openings, perforations or holes.When the melted material of elongate shaft 102 solidifies, an additionalmechanical bonding is created between hypotube 114 and elongate shaft102. In another embodiment of bonding hypotube 114 to elongate shaft102, hypotube 114 is bonded to elongate shaft 102 by an adhesive. Theproximal end of guide device 14 comprises hub 108. In the embodimentshown, hub 108 is a female luer hub. In a preferred embodiment, the luertaper on such a female luer hub conforms to ISO 59471-1986 and ISO59472-1991. Hub 108 may be attached to the outer surface of outer sleeve106. In one embodiment, hub 108 is attached to the outer surface ofouter sleeve 106 by a suitable biocompatible adhesive e.g. Dymax 1191.Hub 108 has two wings to enable a user to turn guide device 14. In apreferred embodiment, the two wings are located in the same plane as theplane of a curve on the distal region of elongate shaft 102 to assistthe user in knowing where the tip of guide device 14 is pointing. Inanother embodiment, one wing can be longer than the other or haveanother indicia of which side of the device the curved tip of located.The guide device design shown in FIGS. 1A-1C is especially suited fortrans-nasal access of the maxillary sinuses.

In a preferred embodiment, the length of atraumatic tip 104 ranges from0.060 to 0.120 inches. The outer and/or inner rim of the distal end ofatraumatic tip 104 may be radiused to reduce or eliminate sharp edgeswhich in turn reduces or minimizes injury to tissue during the use ofguide device 14. In one embodiment, the radius of curvature of theradiused outer and/or inner rim ranges from 0.005 to 0.012 inches. In apreferred embodiment, the tubular element is made of Pebax 40D and hasan outer diameter ranging from 0.115+/−0.001 inches and an innerdiameter ranging from 0.095+/−0.001 inches. Atraumatic tip 104 is fusedto shaft 102 to form a butt joint. The tubular element is preferablydesigned using a suitable material of construction and a suitablemanufacturing process such that there is negligible color bleeding fromatraumatic tip 104. The distal end of guide device 14 also comprises aradiopaque marker 120. In the embodiment shown, radiopaque marker 120 islocated between the distalmost region of elongate shaft 102 andlubricious liner 112. In one embodiment of guide device 14, no portionof radiopaque marker 120 is exposed to bodily fluids. Radiopaque marker120 may be made of suitable biocompatible materials including, but notlimited to, metals, polymers loaded with a radiopaque substance, etc. Inone embodiment, radiopaque marker 120 comprises a platinum marker bandof a length of 0.040+/−0.003 inches. The platinum marker band has anouter diameter of 0.096+/−0.001 inches and an inner diameter of0.092+/−0.0005 inches. In the embodiment shown, the outer diameter ofthe flared distal end of elongate shaft 102 is 0.113+/−0.003 inches andthe length of radiopaque marker is 0.04 inches. The length of atraumatictip 104 ranges from 0.060 to 0.120 inches. The outer rim of atraumatictip 104 is radiused. The distal end of outer sleeve 106 is tapered asshown and covers part of the protruding distal portion 101 of plastictube 112. In a preferred embodiment shown, the outer diameter of thedistal end of outer sleeve 106 is 0.109+/−0.003 inches.

The distal end of atraumatic tip 104 is designed to be as close to thedistal end of radiopaque marker 120 as possible to minimize the lengthof atraumatic tip 104. In one embodiment of a method of manufacturingguide device 14, a PTFE tube that forms lubricious liner 112 is slidinside elongate shaft 102 made of Nylon. The distal end of elongateshaft 102 is flared to create an annular space between the flared distalend of elongate shaft 102 and lubricious liner 112. Thereafter, aplatinum marker band that forms radiopaque marker 120 is slid over thePTFE tube into the annular space between the distal end of elongateshaft 102 and lubricious liner 112. Radiopaque marker 120 is attached toelongate shaft 102 and lubricious liner 112 by a suitable adhesive.Examples of such adhesives include, but are not limited to Loctite™4011, etc. A Pebax tube that forms atraumatic tip 104 is slide overlubricious liner 112 such that the Pebax tube abuts against the distalend of elongate shaft 102. A suitable heat shrink tubing is insertedover guide device 14. The distal end of guide device 14 is heated. Thisfuses the Pebax tube to elongate shaft 102 and also fuses the Pebax tubeto lubricious liner 112. Thereafter, the distal end of the Pebax tubemay be trimmed. One advantage of this embodiment of a method ofmanufacturing guide device 14 is a strong bond between elongate shaft102 made of Nylon and the Pebax tube that forms atraumatic tip 104.Another advantage of this embodiment of a method of manufacturing guidedevice 14 is that the distal most region of the Pebax tube that formsatraumatic tip 104 may be trimmed as close to the distal end of theplatinum marker band to minimize the length of atraumatic tip 104. Suchembodiments comprising a short atraumatic tip 104 enable easiernavigation and/or torquing and/or repositioning of the distal tip ofguide device within the paranasal anatomy with less injury to thepatient.

FIG. 5C shows an enlarged view of the proximal portion of the guidedevice 14 and FIG. 5G shows a cross section through the shaft 102. Asshown, in this example the shaft 102 of the guide device 14 comprises aninner liner 111 surrounded by plastic tube 112 which in turn issurrounded by hypotube 114 which in turn is surrounded by outer sleeve106. In the embodiment shown, hub 108 is attached to the outer surfaceof outer sleeve 106 by a suitable biocompatible adhesive e.g. Dymax1191. Hub 108 comprises a hub lumen 118 that is in fluid communicationwith the lumen enclosed by lubricious liner 112. Hub 118 may be designedsuch that the transition between hub lumen 118 and the lumen enclosed bylubricious liner 112 is smooth. This allows a seamless transition fromhub lumen 118 to the lumen enclosed by lubricious liner 112.

FIG. 5D shows a sectional view of the guide device through the taperedtransition portion of the shaft 102 at the distal end of hypotube 114.As shownm, in this example, the distal end of hypotube 114 terminatesproximal to the distal end of plastic tube 112 and outer sleeve 106covers the distal end of the hypotube 114 and tapers to a reduced outerdiameter at its distal end, thereby providing a smooth outer surfaceover the distal end of hypotube 114. In this example, the length of thetapered region of outer cover 106 is 0.20 inches maximum. Thus, in thismanner, outer cover 106 creates a smooth transition between the distalend of hypotube 114 and the protruding distal portion 101 of plastictube 112.

Method and Device for Manufacture of the Guide Catheter

In one embodiment of a method of introducing a curve in elongate shaft102 of guide device 14, the guide device is gradually bent while apolymeric region of the guide device is heated to a temperature greaterthan the temperature at which the polymeric region softens. For example,FIGS. 2A and 2B show the steps of a method of introducing an angle orcurve in a guide device. FIG. 2A shows a partial sectional view througha bending device 122 comprising a shaping component 124 and a grippingcomponent 126. Shaping component 124 comprises a curved region thatdefines the final radius of the angled or curved region of guide device14. In one embodiment, bending device 122 is designed to detachablyattach one of multiple shaping components 124 wherein each shapingcomponent 124 has a unique shape. A suitable sized beading 128 isintroduced through the lumen of guide device 14 as shown in FIG. 2A.Beading 128 is sized such that the outer diameter of beading 128 isslightly smaller than the diameter of the lumen of guide device 14. In apreferred embodiment, beading 128 is made of PTFE. Thereafter, a heatshrinkable tubing 130 is introduced over guide device 14 and beading128. Heat shrinkable tubing 130 may be made of suitable polymersincluding, but not limited to Fluorinated Ethylene-Propylene (FEP),PTFE, PFA, ETFE, MFA, THV, etc. Thereafter, a region of the combinationof guide device 14, beading 128 and heat shrinkable tubing 130 is fixedto bending device 122. In the embodiment shown in FIG. 2A, a region ofthe combination of guide device 14, beading 128 and heat shrinkabletubing 130 is fixed to bending device 122 by a spring grip 132 attachedto gripping component 126. A region of guide device 14 to be bent isheated. This region of guide device 14 may be heated by convection orradiation. In one method embodiment, the region of guide device 14 to bebent is heated by blowing hot air on the region of guide device 14 to bebent. The hot air may be generated by a hot box. The temperature of thehot air ranges from 320 to 360 degrees F. In another method embodiment,the region of guide device 14 to be bent is heated by radiant heatgenerated from an electrical heater. Thereafter, the region of guidedevice 14 to be bent is bent as shown in FIG. 2B by applying a suitablemechanical bending force. In this embodiment, the region of guide device14 to be bent was bent after heating the region of guide device 14 to bebent. In an alternate embodiment, the region of guide device 14 to bebent was heated while bending the region of guide device 14 to be bent.After bending the region of guide device 14 to be bent, guide device 14is cooled. Guide device 14 is removed from bending device 122. Heatshrinkable tubing 130 and beading 128 are removed from guide device 14.

Various design parameters of the guide devices disclosed herein may bedefined for quality control of the guide devices. Such parameters mayinclude size parameters, shape parameters, tensile force parameters,etc. In one example, guide device 14 is designed to have a bond oftensile strength of 15 N between hub 108 and outer sleeve 106. Inanother example guide device 14 is designed to have a bond of tensilestrength of 15 N between atraumatic tip 104 and elongate sheath 102. Inanother example, guide device 14 is designed to withstand a torque of0.048 N-mapplied by torquing hub 108 relative to the straight region ofguide device 14 distal to label tubing 110. The applied torque of 0.048N-m should not cause kinking or failure of the bond between outer sleeve106 and hypotube 114 or the bond between hub 108 and outer sleeve 106.

Guide device 14 may be used for introducing one or more devices into theanatomy. Examples of such devices include, but are not limited to,over-the-wire balloon catheters, fixed wire balloon catheters,rapid-exchange balloon catheters, guidewires, etc. Guide device 14 mayalso be used for applying suction to or providing lavage to ananatomical region.

It is to be appreciated that the non-removable guide member 22 need notnecessarily extend through or into the catheter shaft 16 and thecatheter shaft 16 need not necessarily be formed of flexible plastic.For example, FIGS. 8-9A show balloon catheter devices 12 d, 12 e havinga curved tubular metal shaft 16 d (FIGS. 8-8A) or a straight tubularmetal shaft 16 e (FIGS. 9-9A) with a balloon 18 mounted thereon. Onopening 202 is formed in the wall of the tubular shaft 16 d, 16 e topermit inflation fluid to be infused into or extracted from the balloon18. A non-removable guide member 200 attached to and extendds from thedistal end DE of the metal shaft 16 d, 16 e. In this example, thenon-removable guide member 200 does not extend substantially into orthrough the shaft 16 d, 16 e as in the embodiments described above.Rather, in this embodiment, the non-removable guide member 200 isattached to and extends distally from the distal end DE of the shaft 16d, 16 e, as shown. This non-removable guide member 200 may be attachedto the shaft 16 d, 16 e by soldering, welding, adhesive, threadedconnection, crimping of the shaft, frictional engagement, or any othersuitable connection technique. Examples of catheters having this type ofconstruction (but lacking the non-removable guide member 22 a) includethose described in United States Patent Application Publication No.2004/0064150A1, issued as U.S. Pat. No. 8,317,816 (Becker), the entiredisclosure of which is expressly incorporated herein by reference.

Method for Dilating the Ostium of a Maxillary Sinus

FIGS. 7A-7E show steps in one example of a method for using the system10 of FIG. 1 to dilate the ostium O of a maxillary sinus MS in a humansubject. Anatomical structures in FIGS. 7A-7E are labeled as follows:

A number of the drawings in this patent application show anatomicalstructures of the ear, nose and throat. In general, these anatomicalstructures are labeled with the following reference letters:

Nasal Cavity NC Frontal Sinus FS Frontal Sinus Ostium FSO Ethmoid SinusES Sphenoid Sinus SS Medial Turbinate MT Maxillary Sinus MS UncinateProcess UP

Initially, as shown in FIG. 7A, the guide catheter 14 is insertedtrans-nasally, advanced through the nasal cavity NC and positioned suchthat its distal end is adjacent to the ostium O of the maxillary sinusMS.

Thereafter, as shown in FIG. 7B, the balloon catheter 12 is insertedthrough the guide catheter 14 causing the distal portion of thenon-removable guide member 22 to pass through the ostium and into thecavity of the maxillary sinus MS.

Then, as seen in FIG. 7C, the balloon catheter 14 is further advanceduntil the entire portion of the non-removable guide member 22 thatprotrudes beyond the distal end of the catheter shaft 16 is curledwithin the maxillary sinus MS and the balloon 18 has exited the distalend of the guide catheter 14 and is positioned within the ostium O. Thepositioning of the balloon within the ostium O may be verified by directvisualization, endoscopically and/or radiographically, as describedelsewhere in this patent application.

Thereafter, as shown in FIG. 7D, the balloon 18 is inflated one or moretimes causing the ostium O to dilate.

Finally, as shown in FIG. 7E, the balloon is deflated and the ballooncatheter 12 and guide catheter 14 are removed. In some cases, the guidecatheter 14 may be allowed to remain in place after removal of theballoon catheter 12 and a lavage fluid, other substance or one or moreother devices (e.g., lavage catheters, balloon catheters, cuttingballoons, cutters, chompers, rotating cutters, rotating drills, rotatingblades, sequential dilators, tapered dilators, punches, dissectors,burs, non-inflating mechanically expandable members, high frequencymechanical vibrators, dilating stents and radiofrequency ablationdevices, microwave ablation devices, laser devices, snares, biopsytools, scopes and devices that deliver diagnostic or therapeutic agents)may be passed through the guide catheter for further treatment of thecondition.

Although the methods and devices disclosed herein are illustrated inconjunction with particular paranasal sinuses, it is understood thatthese methods and devices can be used in other paranasal sinuses as wellas other anatomical passageways of the ear, nose or throat, such asEustachian tube, larynx, and choana.

Optionally, any of the working devices and guide catheters describedherein may be configured or equipped to receive or be advanced over aguidewire or other guide member (e.g., an elongate probe, strand ofsuture material, other elongate member) unless to do so would render thedevice inoperable for its intended purpose. Some of the specificexamples described herein include guidewires, but it is to beappreciated that the use of guidewires and the incorporation ofguidewire lumens is not limited to only the specific examples in whichguidewires or guidewire lumens are shown. The guidewires used in thisinvention may be constructed and coated as is common in the art ofcardiology. This may include the use of coils, tapered or non-taperedcore wires, radiopaque tips and/or entire lengths, shaping ribbons,variations of stiffness, PTFE, silicone, hydrophilic coatings, polymercoatings, etc. For the scope of this invention, these wires may possessdimensions of length between 5 and 75 cm and outer diameter between0.005″ and 0.050″.

Several modalities can be used with the devices and methods disclosedherein for navigation and imaging of the devices within the anatomy. Forexample, the devices disclosed herein may comprise an endoscope forvisualization of the target anatomy. The devices may also compriseultrasound imaging modalities to image the anatomical passageways andother anatomical structures. The devices disclosed herein may compriseone or more magnetic elements especially on the distal end of thedevices. Such magnetic elements may be used to navigate through theanatomy by using external magnetic fields. Such navigation may becontrolled digitally using a computer interface. The devices disclosedherein may also comprise one or more markers (e.g. infra-red markers).The markers can be used to track the precise position and orientation ofthe devices using image guidance techniques. Several other imaging ornavigating modalities including but not limited to fluoroscopic,radiofrequency localization, electromagnetic, magnetic and otherradiative energy based modalities may also be used with the methods anddevices disclosed herein. These imaging and navigation technologies mayalso be referenced by computer directly or indirectly to pre-existing orsimultaneously created 3-D or 2-D data sets which help the doctor placethe devices within the appropriate region of the anatomy.

It is to be appreciated that the invention has been described hereinwith reference to certain examples or embodiments of the invention butthat various additions, deletions, alterations and modifications may bemade to those examples and embodiments without departing from theintended spirit and scope of the invention. For example, any element orattribute of one embodiment or example may be incorporated into or usedwith another embodiment or example, unless to do so would render theembodiment or example unsuitable for its intended use. Also, where thesteps of a method or process are described, listed or claimed in aparticular order, such steps may be performed in any other order unlessto do so would render the embodiment or example un-novel, obvious to aperson of ordinary skill in the relevant art or unsuitable for itsintended use. All reasonable additions, deletions, modifications andalterations are to be considered equivalents of the described examplesand embodiments and are to be included within the scope of the followingclaims.

What is claimed is:
 1. A balloon catheter device for dilating an openingof a paranasal sinus in a human or animal subject, said balloon catheterdevice comprising: a catheter shaft having a proximal end and a distalend; and a non-compliant or semi-compliant balloon mounted on thecatheter shaft, said balloon being positionable within the opening ofthe paranasal sinus while in a non-inflated state and thereafterinflatable to an inflated state such that it will cause dilation of theopening of the paranasal sinus; at least one position indicating elementuseable to determine when the balloon is positioned within the openingof the paranasal sinus; and non-removable guide member, at least aportion of which extends from the distal end of the catheter shaft, saidnon-removable guide member having a limited range of axial movement orno movement relative to the catheter shaft, said non-removable guidemember being advanceable through the opening of the paranasal sinusahead of the catheter shaft, at least a distal portion of saidnon-removable guide member being more flexible in one plane thananother; wherein the balloon catheter device has a length less thanabout 20 cm.
 2. A catheter device according to claim 1 wherein thenon-removable guide member has at least two regions of differingstiffness.
 3. A catheter device according to claim 1 wherein a proximalportion of the non-removable guide member resides within the cathetershaft and a distal portion of the guide member extends beyond the distalend of the catheter shaft.
 4. A catheter device according to claim 3wherein the proximal portion of the non-removable guide member extendsthrough the entire length of the catheter shaft.
 5. A catheter deviceaccording to claim 4 further comprising a hub on the proximal end of thecatheter shaft, wherein the proximal portion of the non-removable guidemember extends into and is anchored within said hub.
 6. A catheterdevice according to claim 5 wherein the hub comprises a port that is incommunication with the balloon to facilitate passage of inflation fluidinto and out of the balloon.
 7. A catheter device according to claim 6wherein the hub comprises a fluid infusion port and wherein thecrimpable element is crimped in a manner that allows fluid to flow pastthe location of the crimp.
 8. A catheter device according to claim 5wherein a portion of the hub includes a crimpable element which iscrimped so as to engage and hold the proximal portion of thenon-removable guide member within the hub.
 9. A catheter deviceaccording to claim 1 wherein the at least one position indicatingelement comprises at least one marker on the catheter shaft, said markerbeing directly or endoscopically visible to the operator when theballoon is positioned within the opening of the paranasal sinus.
 10. Acatheter device according to claim 1 wherein the at least one positionindicating element comprises at least one radiographically visiblemarker disposed on the non-removable guide member.
 11. A catheter deviceaccording to claim 10 wherein the non-removable guide member extendsthrough the region of the catheter shaft where the balloon is mountedand wherein radiographic markers are provided on the non-removable guidemember to mark the location of the balloon.
 12. A catheter deviceaccording to claim 11 wherein the balloon has a working length and thenon-removable guide member comprises first and second radiographicmarkers, one of which is at one end of the balloon's working length andthe other of which is at the other end of the balloon's working length.13. A catheter device according to claim 1 wherein the at least oneradiographically visible marker comprises a first marker marking thedistal end of a working length of the balloon and a second markermarking the proximal end of the working length of the balloon.
 14. Acatheter device according to claim 1 wherein the balloon issubstantially formed of a material selected from the group consistingof: polyethylene terephthalateterephthalate, nylon and polyamide.
 15. Acatheter device according to claim 1 wherein the balloon is capable ofwithstanding pressures of more than 22 atmospheres without bursting. 16.A catheter device according to claim 1 or 15 wherein the balloon iscapable of breaking bone located around the opening of the paranasalsinus.
 17. A catheter device according to claim 16 wherein the balloonis coated with a polymer coating.
 18. A catheter device according toclaim 16 wherein the coating is dip applied.
 19. A catheter deviceaccording to claim 1 wherein the balloon is formed substantially ofpolyethylene terephthalate that is about 0.002 inch thick having apolyurethane coating disposed thereon, said coating being about 0.002inch thick.
 20. A catheter according to claim 1 wherein the balloon isformed substantially of polyethylene terephthalate that is about 0.002inch thick having a polyurethane coating disposed thereon, said coatingbeing about 0.002 inch thick.
 21. A catheter according to claim 1 havinga length of less than about 15 cm.
 22. A catheter according to claim 1having a length of less than about 10 cm.
 23. A catheter deviceaccording to claim 1 wherein the non-removable guide member is formedsubstantially of a material selected from the group consisting ofnickel-titanium alloy and stainless steel.
 24. A catheter deviceaccording to claim 1 wherein a region of the non-removable guide memberadjacent to its distal end comprises a segment of flattened core wiresurrounded by a helical wire coil.
 25. A catheter device according toclaim 24 wherein the segment of flattened core wire has a height of fromabout 0.001 inch to about 0.004 inch.
 26. A catheter device according toclaim 1 wherein the non-removable guide member comprises a wire corehaving a proximal portion, a middle portion and a distal portion, saidproximal portion being of substantially uniform diameter, said middleportion that is smaller in diameter at its distal end than at itsproximal end and a distal portion of substantially uniform diameter. 27.A catheter device according to claim 26 wherein the proximal portion ofthe core wire has a diameter of 0.025 +/−0.0005 inch.
 28. A catheterdevice according to claim 26 wherein the distal portion of the core wireis flattened.
 29. A catheter device according to claim 26 or 28 whereina helical wire coil surrounds the distal portion and at least some ofthe middle portion of the core wire.
 30. A catheter device according toclaim 29 wherein the helical wire coil has an outer diameter of fromabout 0.014 inch to about 0.038 inch.
 31. A catheter device according toclaim 28 wherein the flattened distal portion of the core wire has aflattened thickness of 0.001 to 0.006 inches.
 32. A catheter deviceaccording to claim 1 wherein the non-removable guide member has asubstantially radiolucent proximal region, a radiopaque middle regionand a substantially radiolucent distal region.
 33. A catheter deviceaccording to claim 32 wherein said at least one position indicatingelement comprises the radiopaque middle region of the non-removableguide member.
 34. A catheter device according to claim 33 wherein theballoon has a working length and the position of the radiopaque middleregion is coterminus with the working length of the balloon.
 35. Acatheter device according to claim 1 wherein at least a portion of thenon-removable guide member extending beyond the distal end of thecatheter shaft may be trimmed.
 36. A catheter device according to claim1 wherein the non-removable guide member is secured to the catheterdevice by adhesive.
 37. A catheter device according to claim 1 whereinan outer polymer covering is disposed on at least a portion of thecatheter device.
 38. A catheter device according to claim 37 wherein theouter covering comprises heat-shrinkable material.
 39. A catheter deviceaccording to claim 38 wherein the heat shrinkable material comprisespolyether block amide.
 40. A catheter device according to claim 1wherein the balloon has a working length of about 12 to about 24 mm. 41.A system comprising a balloon catheter device according to claim 1 incombination with a guide catheter having a lumen through which theballoon catheter device is insertable.
 42. A system according to claim41 wherein the guide catheter has a substantially non-removable shape.43. A system according to claim 42 wherein the guide catheter has acurve of between 0 degrees to about 135 degrees.
 44. A system accordingto claim 42 further comprising a tubular outer cover having a distalend.
 45. A system according to claim 44 wherein the outer cover extendsbeyond the distal end of the metal tube but terminates short of thedistal end of the plastic tube.
 46. A system according to claim 45wherein the outer cover has a distal end that is tapered so as toprovide a smooth transition from the outer surface of the plastic tube.47. A system according to claim 42 or 44 further comprising an innerliner lining the lumen of the plastic tube.
 48. A system according toclaim 47 wherein a radiopaque marker is captured between the inner linerand the plastic tube.
 49. A system according to claim 48 wherein thedistal end of the plastic tube stops short of the distal end of theinner liner such that a distal portion of the inner liner protrudesbeyond the distal end of the plastic tube, and wherein an atraumatic tipmember formed of material that is softer than the plastic tube isdisposed about the distal portion of the inner liner.
 50. A systemaccording to claim 41 wherein the guide catheter comprises a metal tubehaving a lumen and a distal end and a plastic tube having a lumen and adistal end, said plastic tube extending coaxially through the lumen ofthe metal tube with a distal portion of the plastic tube extending outof and beyond the distal end of the metal tube.
 51. A system accordingto claim 50 wherein the distal portion of the plastic tube is curved.52. A catheter device according to claim 1 wherein the distal portion ofthe non-removable guide member that extends beyond the end of thecatheter shaft is an atraumatic tip.
 53. A catheter device according toclaim 1 wherein at least a portion of the non-removable guide member iscoated.
 54. A catheter device according to claim 1 wherein the balloonis coated with a polymer coating and at least a portion of thenon-removable guide member is coated with a different coating.
 55. Acatheter device according to claim 1 wherein the catheter shaft isflexible.
 56. A catheter device according to claim 1 wherein thecatheter shaft is formed of plastic.
 57. A catheter device according toclaim 1 wherein the catheter shaft is formed of metal.
 58. A catheterdevice according to claim 57 wherein the catheter shaft is formed ofmetal hypotube.
 59. A catheter device according to claim 57 wherein thecatheter shaft is formed of straight metal tube.
 60. A catheter deviceaccording to claim 57 wherein the catheter shaft is formed of curvedmetal tube.